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Comprehensive Analysis of Relapse in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acthar Gel

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Acthar Gel, MS relapse, 7T MRI imaging, Quality of Life

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients will be eligible to participate in the study if:

They were diagnosed with Relapsing-Remitting Multiple Sclerosis within 1 year of their participation in the study Are established patients of the Tanner Center for MS Seek care for relapse within 72 hours of onset Are between the ages of 19 and 65 inclusively.

Relapse will be confirmed and defined as the acute worsening of function that lasts for at least 24 hours with any of the manifestations of Central Nervous System relapses (excluding spinal cord) including:

Brain stem syndrome Optic neuritis Cerebellar syndromes Hemi-motor/sensory events Males and Females are both eligible Patients of any race or ethnicity are eligible Are not pregnant (as confirmed by pregnancy test at the time of enrollment) or nursing Have no known contraindicating conditions (see exclusions)

Exclusion Criteria:

Potential participants will be excluded if they do not meet the above criteria, and also if:

They are currently being treated for MS with the any of the following disease-modifying drugs: Tysabri, Gilenya, Aubagio, Tecfidera They have a history of experiencing significant adverse reactions to corticosteroids They are deemed by Dr Riser to be better served with an intervention other than Acthar Gel to treat their current MS relapse Are pregnant or nursing

Are known to have any of the contraindicating conditions:

Scleroderm Osteoporosis Systemic fungal infections Ocular herpes simplex Recent surgery History of or presence of peptic ulcer Congestive heart failure Uncontrolled hypertension Adreno-cortical insufficiency, hyper-function or sensitivity Sensitivity to proteins of porcine origin

Sites / Locations

Tanner Center for MS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acthar Gel

Arm Description

Acthar Gel is supplied as 5 mL multi-dose vial (63004-8710-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection). Acthar Gel will be administered as a subcutaneous daily dose of 80 units for up to 2 weeks.

Outcomes

Primary Outcome Measures

Changes in immunorepertoire, MRI imaging, clinical outcomes and patient reported quality of life

This study will observe changes in the activity of b cells and t cells as evidenced in the patient's immunorepertoire, as well as changes in 7T MRI images, physician-documented clinical outcomes in patients receiving Acthar Gel for treatment of MS relapse at four time points: baseline, 5, 14 and 30 days post initiation of treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT01906684

First Posted

July 19, 2013

Last Updated

July 31, 2013

Sponsor

Tanner Foundation for Multiple Sclerosis

Collaborators

Mallinckrodt, Auburn University MRI Research Center, iReportoire Inc

1. Study Identification

Unique Protocol Identification Number

NCT01906684

Brief Title

Comprehensive Analysis of Relapse in Multiple Sclerosis

Official Title

Comprehensive Analysis of Relapse in Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

August 2013 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tanner Foundation for Multiple Sclerosis

Collaborators

Mallinckrodt, Auburn University MRI Research Center, iReportoire Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will determine changes in: 1) the immune activity, characterized as the "immunorepertoire;" 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient reported quality of life outcomes in subjects with relapsing-remitting multiple sclerosis who are treated with Acthar Gel.

Detailed Description

20 patients with documented Multiple Sclerosis, who have been diagnosed within 12 months of enrollment in the study and who are currently experiencing an MS relapse, defined as the following manifestation: Acute onset or worsening of any of the manifestations of CNS relapses (excluding spinal cord) including: Brain stem syndrome Optic neuritis Cerebellar syndromes If they choose to participate, subjects will be asked to: Meet at the Clinic 4 times: Initial visit 5 days after baseline visit 14 days after baseline visit 30 days after baseline visit Meet with neurologist for neurological exam that will include a: Review of neurological status Review of new and ongoing symptoms Review of symptom resolution Review of any side effects or adverse events Resolution of any patient questions and concerns Provide a 40cc whole blood sample At each of the 4 visits Consent to Acthar Gel treatment for their relapse for 14 days (or as required for their relapse) Ss will agree to be trained in self-administration of Acthar First dose administered at Baseline visit Self-administered days 2-14 of participation Complete 4 psychometric instruments At baseline and 30 day visit Cognitive assessment using the Brief International Cognitive Assessment for MS (Benedict 2012) Administered by Tanner Center Staff specially trained in this assessment Quality of Life assessments: self-administered MSQoL (Cella et al, 1006) Psychological Adjustment to Illness Survey (Rodrigue et al 2000) Coping Skills Inventory (Liveneh, 2003) Participate in a brief semi-structured interview, at Day 5 visit

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Acthar Gel, MS relapse, 7T MRI imaging, Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acthar Gel

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Acthar Gel

Intervention Description

Patients who present with MS relapse within 72 hours of onset will be recruited for study. Upon consent they will be administered Achtar Gel for 5-14 days as clinically appropriate.

Primary Outcome Measure Information:

Title

Changes in immunorepertoire, MRI imaging, clinical outcomes and patient reported quality of life

Description

Time Frame

within 1 month post initiation of treatment with Acthar Gel

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients will be eligible to participate in the study if: They were diagnosed with Relapsing-Remitting Multiple Sclerosis within 1 year of their participation in the study Are established patients of the Tanner Center for MS Seek care for relapse within 72 hours of onset Are between the ages of 19 and 65 inclusively. Relapse will be confirmed and defined as the acute worsening of function that lasts for at least 24 hours with any of the manifestations of Central Nervous System relapses (excluding spinal cord) including: Brain stem syndrome Optic neuritis Cerebellar syndromes Hemi-motor/sensory events Males and Females are both eligible Patients of any race or ethnicity are eligible Are not pregnant (as confirmed by pregnancy test at the time of enrollment) or nursing Have no known contraindicating conditions (see exclusions) Exclusion Criteria: Potential participants will be excluded if they do not meet the above criteria, and also if: They are currently being treated for MS with the any of the following disease-modifying drugs: Tysabri, Gilenya, Aubagio, Tecfidera They have a history of experiencing significant adverse reactions to corticosteroids They are deemed by Dr Riser to be better served with an intervention other than Acthar Gel to treat their current MS relapse Are pregnant or nursing Are known to have any of the contraindicating conditions: Scleroderm Osteoporosis Systemic fungal infections Ocular herpes simplex Recent surgery History of or presence of peptic ulcer Congestive heart failure Uncontrolled hypertension Adreno-cortical insufficiency, hyper-function or sensitivity Sensitivity to proteins of porcine origin

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ritalinda D Lee, PhD

Phone

256-714-0683

rlee@tannerms.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily S Riser, MD

Organizational Affiliation

Tanner Center for MS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tanner Center for MS

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emily S Riser, MD

12. IPD Sharing Statement

Learn more about this trial

Comprehensive Analysis of Relapse in Multiple Sclerosis

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